DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claim
Claims 1-5, 7, 9-38 are pending and under examination; Claims 1-5, 7, 9-13 and 30-31 are under examination. Claims 14-29 and 32-38 are withdrawn from consideration. Any objections or rejections not repeated below have been withdrawn.
Claim Objections
Claims 1 is objected to because of the following informality:
Claim 1 line 1 recites, “A a non-animal based protein concentrate.” The word “a” is repeated twice. An “a” should be deleted. The limitation would then read as follows, “A non-animal based protein concentrate.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 7, 9-13 and 30-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 lines 2-4 recite, “a fermented plant product generated under fermentation conditions selected to limit formation of viscosity-increasing exopolysaccharides.” However, upon further review this limitation is broader than what is stated in the specification. Paragraph 22 of the specification states, “…drying the fermented cake, where the at least one microbe does not generate sufficient exopolysaccharides to produce a viscous fermented cake.” Paragraph 107 of the specification states, “…microorganisms exhibit low exopolysaccharide production.” Thus, according to the specification the specific fermentation condition that limits formation of viscosity-increasing exopolysaccharides is “the at least one microbe,” as stated in paragraph 22, or “microorganisms,” as stated in paragraph 107. There is not sufficient support for the generic “fermentation conditions” disclosed in claim 1, which would include other conditions such as temperature, time, media type, etc., as well as the microbe. Therefore, the claim limitation is considered new matter since it is not present in the disclosure.
Claim 4 lines 8-9 recite, “wherein the concentrate has a protein-to-ash ratio of between about 16:1 and about 30:1 on a dry matter basis." However, upon further review of the specification it is found that this limitation is never disclosed in the specification, specifically the specification does not state that the concentrate has a specific protein-to-ash ratio. Even if this ratio is present in some form with the amount of protein and the amount of ash, there is nothing in the specification to support having a specific ratio range of protein-to-ash. Thus, the claim limitation is considered new matter since it is not present in the disclosure.
Claims 2-3, 5, 7, 9-13 and 30-31 are included in the rejection because they depend from a rejected base claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 12-13 and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Gibbons et al. US 20130142905 in view of Hwang et al. US 20090093406 and DuPonte, Livestock Feed Analysis, 1998, https://www.ctahr.hawaii.edu/oc/freepubs/pdf/livestock_feed_analysis.pdf (hereinafter, DuPonte).
Regarding claim 1, Gibbons discloses a non-animal based protein concentrate (a high quality protein concentrate (HQPC) from plant material; Abstract, [0010], [0012], Claims 1 and 2), comprising a fermented plant product (where the incubation process may include fermentation; [0040]).
The recitations within the claim of “generated under fermentation conditions selected to limit formation of viscosity-increasing exopolysaccharides” does not limit the claim, but is merely directed towards process steps and conditions to make the final product instead of the final product itself. See MPEP 2113.I. Therefore, if the product in the product-by-process recitation in claim 1, is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.
Regardless, the process of the prior art meets the claimed limitation of, “generated under fermentation conditions selected to limit formation of viscosity-increasing exopolysaccharides.” As discussed in the instant specification paragraphs 22 and 107, the at least one microbe is the fermentation condition that is selected to limit formation of the viscosity increasing exopolysaccharides. Gibbons discloses the concentrate comprises a microbe, wherein the microbe is Aureobasidium pullulans (A. pullulans) [0014]. The instant specification also discloses A. pullulans as the microbe [0010]. Thus, Gibbons is considered to meet the claimed limitation as recited above.
Gibbons states the protein concentrate comprises a protein content in the range of from about 56% to about 90% on a dry matter basis [0013], which encompasses the claimed range of at least 65% to about 75% protein content. See MPEP 2144.05(I).
Gibbons teaches the composition has an ash content of 5.21% (pg. 13 Table 2, Trial 6). Gibbons does not teach an ash content of less than about 4%.
Hwang teaches a vegetable protein composition derived from washed vegetable protein material (Abstract, [0003]). Hwang discloses the washing of soy protein is done to remove large amounts of soluble materials in combination with centrifugation process and may be repeated one or more times by taking the centrifuge cake of the first centrifugation and diluting with water and then putting through the centrifuge again, or in other words by washing with water one or more times. Hwang states that the slurry, after removing the soluble components by the above separation process, has an increase in protein content and has a reduced ash content due to the removal of minerals [0097-0098]. The instant specification outlines a process to achieve an ash content in the composition of not greater than about 4% by washing the cake with one or more solvents and/or downstream centrate and then separating the one or more solvents from the cake through centrifugation and repeating this process up to three times ([0122] and Fig. 6). The method of the instant specification to obtain an ash content of less than about 4% is the same process used by Hwang, of repeatedly washing the cake (soy protein) with a solvent (water).
Further regarding the particular ash content, DuPonte teaches the analysis of livestock feed, specifically ash content. DuPonte states that ash is not digestible by animals and high ash content of feeds may dilute the amount of nutrients available to the animal (pg. 1 [0001]; pg. 2, row 2 titled, “Ash = total inorganic matter”, column 2). Therefore, the reference is teaching that it has been known and desirable to remove ash to prevent dilution of nutrients available to the animal.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Gibbons by washing the protein concentrate with water in a repeated washing process as taught by Hwang, to obtain an ash content of less than about 4% because ash is not digestible by animals and a high ash content would dilute the amount of nutrients available to the animal, as recognized by DuPonte.
Regarding the recitation, “and a degree of hydrolysis (DH) of at least about 10%,” the specification [0081] defines “degree of hydrolysis” to mean the proportion of cleaved peptide bonds in a protein hydrolysate. Thus, the degree of hydrolysis is directed towards protein hydrolysis and not another form of hydrolysis.
Additionally, regarding the above recitation, it is noted that Gibbons teaches a method that is substantially identical to the methods disclosed in the instant specification. Specifically, Gibbons teaches inoculating the mash by adding 1% v/v of Aureobasidium pullulans (A. pullulans) and incubating; while incubating adding sterile air at a rate of 0.5-1 L/L/h, incubating at about 30-37 °C for less than about 96 hours [0025], [0058], [0111]. The instant specification teaches inoculating the mash with about 1% v/v of A. pullulans and incubating; while incubating adding sterile air at a rate of 0.5-1 L/L/h, incubating at about 30°C for about 7 to 24 hours [00115]. It is noted that A. pullulans produce and secrete proteolytic enzymes which would hydrolyze the proteins, creating a certain degree of hydrolysis. Thus, the reference would have necessarily taught a degree of hydrolysis of at least about 10%. See MPEP 2112. "In relying upon the theory of inherency, the examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art." Ex parte Levy, 17 USPQ2d 1461, 1464 (Bd. Pat. App. & Inter. 1990).
Regarding claim 2, modified Gibbons teaches the concentrate of claim 1, as discussed above. Gibbons discloses the concentrate comprises a microbe, wherein the microbe is Aureobasidium pullulans (A. pullulans) [0014]. Regarding the recitation, “which A. pullulans produces less than about 3.0g/L pullulan when grown in a medium comprising between 0.35 and 0.5 g/L yeast extract,” This recitation is directed towards an intended use of the A. pullulans and does not specify any amount of A. pullulans. Since the Gibbons reference teaches the addition of a A. pullulans, it would be capable of the intended use of producing less than about 3.0 g/L pullulan when grown in a medium comprising between 0.35 and 0.5 g/L yeast extract.
Regarding claim 3, modified Gibbons discloses the concentrate of claim 1, as discussed above. Gibbons teaches the non-animal based protein concentrate is derived from plant material from the group consisting of soybeans, peanuts, rapeseeds, barley, canola, peas, sesame seeds, cottonseeds, palm kernels, barley, grape seeds, olives, safflowers, sunflowers, copra, corn, coconuts, linseed, hazelnuts, wheat, rice, potatoes, cassavas, legumes, camelina seeds, mustard seeds, germ meal, corn gluten meal, distillery/brewery by-products, and combinations thereof [0012], [0045].
The recitation, “wherein the fermented plant product is generated under fermentation conditions comprising incubation of the plant material for between about 7 hours and about 14 hours” does not limit the claim, but is merely directed towards process steps and conditions to make the final product instead of the final product itself. See MPEP 2113.I. Therefore, if the product in the product-by-process recitation in claim 3, is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.
Regardless, the process of the prior art, Gibbons, meets the claimed limitation of, wherein the fermented plant product is generated under fermentation conditions comprising incubation of the plant material for less than about 96 hours [0058], which is within the claimed range of between about 7 and about 14 hours. See MPEP 2123 and 2144.05(I).
Regarding claim 4, modified Gibbons discloses the concentrate of claim 1, as discussed above. Gibbons teaches the plant material is from soybeans in the form of soy flakes or soy meal (soybean meal; [0015]).
Regarding the recitation, “wherein said non-animal based protein concentrate exhibits one or more of the properties selected from the group consisting of a significant shift downward in raw NIR spectra between 4664 cm-1 and 4863 cm-1 for the composition relative to soy flakes or soy meal from which said non-animal based protein concentrate is derived, a potassium content of less than about 0.1 ppm and magnesium content of less than about 0.1ppm and a combination thereof,” this recitation is directed toward properties of the claimed composition. When comparing Figure 1 in the specification, [0042], that shows a flow chart for the conversion process of high quality soy protein concentrate (HQSPC) to Figure 1 of Gibbons, which also shows the conversion process of HQSPC, these figures are identical in method steps and conditions. It would have been reasonable for one having ordinary skill in the art to expect that when these method steps of Gibbons are combined with the extra washing method steps of Hwang, a substantially identical product to the claimed product is produced. Since Gibbons in view of Hwang and DuPonte is substantially identical to the claimed product, it is considered to possess the property of a significant shift downward in raw NIR spectra between 4664 cm-1 and 4863 cm-1 for the composition relative to soy flakes or soy meal from which said non-animal based protein concentrate is derived, a potassium content of less than about 0.1 ppm and a magnesium content of less than about 0.1ppm and a combination thereof, as required by claim 4. As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. [citation omitted] Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. See MPEP §2112.01 (I).
Gibbons discloses the concentrate has a protein amount from about 56% to about 90% on a dry matter basis [0013] and modified Gibbons teaches an ash content of less than about 4%, for example an ash content of about 3%, see rejection for claim 1 above. Thus, modified Gibbons teaches a protein-to-ash ratio range of between about 19:1 to about 30:1. This is within the claimed range of between about 16:1 and about 30:1.
Regarding claim 12, modified Gibbons discloses the concentrate of claim 1, as discussed above. Gibbons teaches the plant material is soy meal (soybean meal; [0015]), the composition has a protein content in the range of from about 56% to about 90% on a dry matter basis [0013], which encompasses the claimed range of at least 70% protein content.
Gibbons in view of Hwang and DuPonte teaches an ash content of less than about 4%, as shown above in claim 1, which encompasses the claimed range of ash content of less than 2.5%. See MPEP 2144.05(I).
Regarding the recitation, “exhibits a significant shift downward in raw NIR spectra between 4664 cm-1 and 4863 cm-1 relative to soy meal from which said non-animal based protein concentrate is derived and has a potassium content of less than about 0.1 ppm and magnesium content of less than about 0.1ppm.” As stated above in claim 4, Gibbons in view of Hwang and DuPonte is substantially identical to the claimed product. Since Gibbons in view of Hwang and DuPonte is substantially identical to the claimed product, it is considered to possess the property of a significant shift downward in raw NIR spectra between 4664 cm-1 and 4863 cm-1 relative to the soy meal from which it is derived and has a potassium and magnesium content of less than about 0.1ppm, as required by claim 12. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
Regarding claim 13, modified Gibbons discloses the concentrate of claim 12, as discussed above. Modified Gibbons teaches a composition wherein the shift downward is between about 10% to about 20%. As stated above in claim 12, Gibbons in view of Hwang and DuPonte is substantially identical to the claimed product. Since Gibbons in view of Hwang and DuPonte is substantially identical to the claimed product, it is considered to possess the property of a shift downward of between about 10% to about 20%, as required by claim 13. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
Regarding claims 30 and 31, modified Gibbons discloses the concentrate of claim 12, as discussed above. Modified Gibbons teaches wherein the plant product is soy meal (soybean meal; [0015]), and there is at least a 10% shift downward raw NIR spectra between 4664 cm-1 and 4863 cm-1 for the non-animal based protein concentrate relative to the soy meal from which the non-animal based protein concentrate is derived, as required by claim 30; and wherein the shift downward is about 20%, as required by claim 31. As stated above in claims 4 and 12, Gibbons in view of Hwang and DuPonte is substantially identical to the claimed product. Since Gibbons in view of Hwang and DuPonte is substantially identical to the claimed product, it is considered to possess the property of at least a 10% shift downward raw NIR spectra between 4664 cm-1 and 4863 cm-1 for the non-animal based protein concentrate relative to the soy meal from which the non-animal based protein concentrate is derived, as required by claim 30; and wherein the shift downward is about 20%, as required by claim 31. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
Claims 5, 7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Gibbons et al. US 20130142905 in view of Hwang et al. US 20090093406 and DuPonte, Livestock Feed Analysis as applied to claim 1 above, and further in view of Chang et al. US 20090123629.
Regarding claims 5, 7 and 9, modified Gibbons discloses the concentrate of claim 1, as discussed above. Modified Gibbons teaches the foodstuff (food supplement for humans; [0010], [0037], [0093]) comprising the concentrate, as required by claim 5; wherein the foodstuff is for human consumption (food supplement for humans; [0010], [0037], [0093]), as disclosed in claim 9. Gibbons does not teach the composition is combined with at least one meat substitute, as required by claim 5.
Chang teaches a non-animal based protein concentrate (plant protein concentrate; [0021]) that is combined with a meat substitute, as required by claim 5, where the meat substitute is tofu, as required by claim 7 (Abstract, [0002], [0004]). Chang discloses when the protein concentrate and tofu are combined this improves the texture and eating quality characteristics to achieve a texture similar to those of animal meat while providing an improved nutritional profile, i.e. a higher percentage of protein and lower percentages of both fat and cholesterol [0014].
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Gibbons in view of Hwang and DuPonte to add the composition of claim 1 to the tofu of Chang, because when combined this improves the texture and eating quality characteristics to achieve a texture similar to those of animal meat while providing an improved nutritional profile, i.e. a higher percentage of protein and lower percentages of both fat and cholesterol, as recognized by Chang [0014].
Regarding claim 10, modified Gibbons discloses the concentrate of claim 5, as discussed above. Gibbons teaches wherein the feed is formulated for animals selected from the group consisting of fin fish (bluegill sunfish, bass, salmon, trout; [0018]), shell fish (mollusks) crustaceans, domestic animals (cat, dog), farm animals (cattle, swine, sheep) and a combination thereof [0010], [0037].
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gibbons et al. US 20130142905 in view of Hwang et al. US 20090093406 and DuPonte, Livestock Feed Analysis as applied to claim 2 above, and further in view of Gibbons and Croat US 20160242435 (hereinafter Croat).
Regarding claim 11, modified Gibbons discloses the concentrate of claim 2, as discussed above. Gibbons teaches the A. pullulans is a strain selected from the group consisting of NRRL No. 50792, NRRL No. 50793, NRRL No. 50794, and NRRL No. 50795 [0027]. Gibbons does not disclose the strain NRRL-Y-2311-1.
Croat teaches a non-animal based (canola) protein concentrate containing a microbe [0004], [0011], [0018]. Croat discloses the microbe is A. pullulans where the specific strain of A. pullulans is NRRL-Y-2311-1 [0018], [0057]. Croat uses this strain because it is one of the strains that resulted in the greatest improvement of protein content [0057].
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Gibbons in view of Hwang and DuPonte to have used the A. pullulans strain of Croat because the strain NRRL-Y-2311-1 exhibits a great improvement in protein content when used, as recognized by Croat [0057].
Gibbons states the concentrate has a lipid content of at least about 1.25 g of lipid/100 g composition, or at least about 1.25% lipid content on a dry matter basis [0017]. This encompasses the claimed range of about 3% (dry matter basis). See MPEP 2144.05(I).
Response to Arguments
Applicant's arguments filed 05/18/2026 have been fully considered but they are not persuasive.
Rejections Under 35 U.S.C. §103
Applicant argues, on pgs. 10-11 of their remarks, that nothing in Gibbons suggests substantially shortened fermentation conditions, such as the disclosed incubation periods of about 7-14 hours. Applicant states that Gibbons explores extended microbial processing conditions and does not recognize the presently claimed controlled shortened fermentation conditions directed toward limiting formation of viscosity-increasing exopolysaccharides while still achieving the presently claimed compositional profile. However, the Office disagrees for the following reasons.
As discussed above, Gibbons does teach the incubation time. Gibbons discloses wherein the fermented plant product is generated under fermentation conditions comprising incubation of the plant material for less than about 96 hours [0058], which is within the claimed range of between about 7 and about 14 hours. See MPEP 2123 and 2144.05(I).
Additionally, the recitation, “wherein the fermented plant product is generated under fermentation conditions comprising incubation of the plant material for between about 7 hours and about 14 hours” does not limit the claim, but is merely directed towards process steps and conditions to make the final product instead of the final product itself. See MPEP 2113.I.
Regarding the claimed limitation of, “generated under fermentation conditions selected to limit formation of viscosity-increasing exopolysaccharides,” as discussed in the instant specification paragraphs 22 and 107, the at least one microbe is the fermentation condition that is selected to limit formation of the viscosity increasing exopolysaccharides. Gibbons discloses the concentrate comprises a microbe, wherein the microbe is Aureobasidium pullulans (A. pullulans) [0014]. The instant specification also discloses A. pullulans as the microbe [0010]. Thus, Gibbons is considered to meet the claimed limitation as recited above. While other fermentation conditions will factor into limiting the formation of viscosity-increasing exopolysaccharides, these conditions are not specifically outlined and connected to this limitation in the disclosure, only the at least one microbe is discussed in relation to limiting this formation during incubation.
Moreover, in response to applicant's argument that Gibbons does not recognize the presently claimed controlled shortened fermentation conditions directed toward limiting formation of viscosity-increasing exopolysaccharides while still achieving the presently claimed compositional profile, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant argues, on pgs. 11-12, that the rejection relies upon inconsistent treatment of the cited references. Applicant contends that the rejection relies on Hwang for teaching the washing of protein materials, while simultaneously asserting that Gibbons is not limited to alcohol-washed systems. The secondary reference expressly performs all of its disclosed washing procedures on “alcohol washed vegetable protein material” not untreated fermented plant substrates. Applicant argues that the washing behavior and resulting compositional characteristics disclosed in the secondary reference are tied to an already alcohol-treated starting material. Applicant argues the rejection does not adequately explain why a person of ordinary skill in the art would have reasonably expected the washing teachings of Hwang to apply to the materially different fermentation systems of Gibbons, particularly where the presently claimed compositions do not require alcohol washing. Applicant believes the proposed modification to the secondary reference, Hwang, would materially alter the operative context underlying the secondary reference’s disclosed washing process. Applicant concludes, stating the rejection relies upon hindsight reconstruction of Applicant’s claimed invention rather than teachings or suggestions in the cited references. However, the Office disagrees for the following reasons.
The rejection above does adequately explain why a person of ordinary skill in the art would have reasonably expected the washing teachings of Hwang to apply to the concentrate of Gibbons. Hwang discloses the washing of soy protein is done to remove soluble materials. Hwang states that the slurry, after removing the soluble components, has an increase in protein content and has a reduced ash content due to the removal of minerals [0097-0098]. Thus, washing the soy protein with water is used to remove ash from the concentrate, or used to reduce the mineral content. DuPonte teaches the analysis of livestock feed, specifically ash content. DuPonte states that ash is not digestible by animals and high ash content of feeds may dilute the amount of nutrients available to the animal (pg. 1 [0001]; pg. 2, row 2 titled, “Ash = total inorganic matter”, column 2). Therefore, the reference is teaching that it has been known and desirable to remove ash to prevent dilution of nutrients available to the animal. Also, Hwang teaches a water washing method that removes/lowers the ash content of the concentrate. Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Gibbons by washing the protein concentrate with water in a repeated washing process as taught by Hwang, to obtain an ash content of less than about 4% because ash is not digestible by animals and a high ash content would dilute the amount of nutrients available to the animal, as recognized by DuPonte.
Additionally, Hwang is used as teaching reference to show how repeated washings with water can lower the ash content of the concentrate. Hwang’s disclosure of an alcohol-treated starting material is not a critical element when looking at the combination of references. Hwang is specifically used to modify Gibbons for its water washing steps to lower the ash content of the concentrate, see rejection above. These modifications of Gibbons in view of Hwang are independent of Hwang’s alcohol-treated starting material. Therefore, even though the secondary reference does disclose an alcohol treated starting material, the combination of Gibbons and Hwang still would make obvious all the claimed limitations, including the ash content. Additionally, Hwang is not viewed as having the operative context materially altered, since it is Gibbons, not Hwang, that is being modified with the washing step that is known to lower ash content.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Moreover, in response to applicant's argument that Hwang requires an alcohol-treated starting material, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant argues, on pgs. 13-15, that there is no motivation to combine a fermented plant protein concentrate as an extrusion-precursor because the starting material of Chang requires substantially aligned protein fibers and A. pullulans is known to produce proteases and peptidases that would degrade the fiber structure. Applicant contends that the rejection again relies on hindsight reconstruction of Applicant’s claimed invention rather than teachings or suggestions in the cited references. Applicant also contends that a person skilled in the art would not have a reasonable expectation of success modifying Gibbons in view of Chang since a skilled artisan could not predict the potential effects of native extracellular, A. pullulans protease and peptidase activities on the aligned fiber structures of Chang. However, the Office disagrees for the following reasons.
Chang is used as a teaching reference to show that a non-animal based protein concentrate (plant protein concentrate; [0021]) can be combined with a meat substitute, such as tofu. Chang discloses when the protein concentrate and tofu are combined this improves the nutritional profile, i.e. a higher percentage of protein and lower percentages of both fat and cholesterol [0014]. Chang’s disclosure of aligned fiber structures is not a critical element when looking at the combination of references. Chang is specifically used to modify Gibbons for its combination of protein concentrate with a meat substitute, specifically tofu, see rejection above. The modifications of Gibbons in view of Chang are independent of Chang’s aligned fiber structure. Therefore, even though the secondary reference does disclose an aligned protein fiber structure, the combination of Gibbons and Chang still would make obvious all the claimed limitations, including the combination of protein concentrate with a tofu meat substitute.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
A person skilled in the art would have a reasonable expectation of success modifying Gibbons in view of Chang. A person of ordinary skill, when reviewing prior art, would observe in the Chang reference that combining non-animal based protein concentrate (plant protein concentrate; [0021]) with a tofu meat substitute, improves the nutritional profile of the composition, i.e. a higher percentage of protein and lower percentages of both fat and cholesterol [0014]. Thus, a person of ordinary skill would have had motivation to combine and a reasonable expectation of success since Chang was able to successfully combine a protein concentrate with a tofu meat substitute, creating a foodstuff that has improved nutrition.
Moreover, in response to applicant's argument that Chang requires substantially aligned protein fibers, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant argues, on pg. 15, that the Office selectively relies upon A. pullulans strain NRRL-Y-2311 from among multiple strains disclosed in Croat. Applicant also states that even selecting the cited NRRL-Y-2311 strain, Croat does not disclose the presently claimed ash content. However, the Office disagrees for the following reasons.
While Croat does disclose multiple strains of A. pullulans, as stated in MPEP 2123, “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).” Thus, it is reasonable for a person of ordinary skill to have selected the NRRL-Y-2311 strain, since it is taught in the prior art and there is motivation in Croat to use the strain because it is one of the strains that resulted in the greatest improvement of protein content [0057]. Additionally, as shown by the above rejection modified Gibbons teaches a composition that has an ash content as claimed. The Croat reference is not used to teach the claimed ash content.
Moreover, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.R.G./Examiner, Art Unit 1791
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759
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